Myelodysplastic Syndrome (MDS), FISH

Casandra

Casandra Test Code LC66925Version 1 (DRAFT)

Performing Lab

Lab LabcorpLab Test ID 511060

Myelodysplastic Syndrome (MDS), FISH

Clinical Use

Use

Diagnostic test for myelodysplastic syndrome. The principal use is for interphase analysis of cases with no (or low) mitotic activity in cytogenetic analysis or interphase analysis from blood in cases of inaspirable bone marrow. Detection rate is approximately 80% of clones detected in cytogenetic analysis.

Special Instructions

Not provided.

Limitations

This test is limited to detecting chromosomal abnormalities targeted by the specific DNA probes included in the study. Molecular mutations or chromosomal alterations not targeted by these probes will not be detected. Results should be interpreted in conjunction with a full cytogenetic analysis and hematologic evaluation. It is important to note that the test has not been cleared or approved by the FDA, but the FDA has determined that such clearance or approval is not necessary.

Test Details

Methodology

Chromosomal / Cytogenetics (FISH)

Biomarkers

4 targets

Unknown CNVUnknown CNVUnknown CNVUnknown CNV

LOINC Codes

Order Codes

31208-2 - Specimen source
48672-0 - Clinical cytogeneticist Spec
50398-7 - Narrative diagnostic report-Imp
57802-1 - Chrom analy interphase Bld/Mar FISH-Imp
62360-3 - Cells analyzed
62361-1 - Cells counted

Result Codes

62361-1 - Cells counted
62360-3 - Cells analyzed
57802-1 - Chrom analy interphase Bld/Mar FISH-Imp
50398-7 - Narrative diagnostic report-Imp
31208-2 - Specimen source
48672-0 - Clinical cytogeneticist Spec

Result Turnaround Time

3-5 days

Specimen

Whole Blood

Volume

5 mL

Minimum Volume

1 mL

Container

Green-top (sodium heparin) tube; pediatric Vacutainer® is optimal or lavender-top (EDTA) tube (suboptimal)

Collection Instructions

Utilize sterile technique and Labcorp transport kits when possible.

Storage Instructions

Transport to the testing laboratory at room temperature; use of a cool pack or a Labcorp transport kit is acceptable. Do not allow samples to overheat or freeze.